In Canada a Clinical Trial Application (CTA) must be filed before starting a clinical trial. Health Canada will review the application and will notify the sponsor within 30 days if it is found to be deficient.[2]

In Europe, the application process to perform a clinical trial takes place on a country-by-country basis. A sponsor must apply for approval in each country in which it intends to have study sites. A sponsor also must register their proposed clinical trial in EudraCT, a database of all in European clinical trials that is operated by the European Medicines Agency.[3]